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FDA still mulling EHR software regulation

Outside D.C., talk of the FDA regulating EHR software might have died down, but the agency still is determining how it will move forward and complement the work of the ONC.

WASHINGTON, D.C. -- A Food and Drug Administration official confirmed in a conversation with that the FDA is quietly moving forward in its quest to regulate the safety of electronic health record (EHR) software.

The agency had planned to release more details about its EHR safety push at some point before the midterm elections, Bakul Patel of the FDA's Center for Devices and Radiological Health (CDRH) said at the recent mHealth Summit. Since then, FDA officials have reopened internal discussions about the best way for the agency to go about regulating EHR software and collecting adverse event reports, and "debating the pros and cons of different approaches," he said.

"The elections put it on pause, but it's starting up again," Patel said. The nature of the health IT infrastructure itself complicates the issue, because of the way EHR systems have a "multitude of interactions with multiple software [applications]," he later said.

Public awareness of EHR safety grows

Late last February, at the behest of U.S. Sen. Charles Grassley (R-Iowa), CDRH director Dr. Jeffrey Shuren testified before the Health Information Technology (HIT) Policy Committee Adoption/Certification Workgroup. Health IT devices -- EHR software included -- show much potential for improving patient care, but pose serious safety concerns, Shuren said. The FDA was considering how to build a regulatory framework around health IT to assure patient safety, he added.

Cardiology health systems are also regulated. We've been doing this since [the 1990s]. It's nothing new.

Bakul Patel, FDA's Center for Devices and Radiological Health

"In the past two years, we have received 260 reports of HIT-related malfunctions with the potential for patient harm -- including 44 reported injuries and [six] reported deaths," Shuren testified. "Because these reports are purely voluntary, they may represent only the tip of the iceberg in terms of the HIT-related problems that exist."

In August, the Huffington Post website raised consumers' awareness of EHR safety when it published an investigative report detailing the consequences of real-life incidents, and intimated that divisions within the Obama administration were holding up safety regulations.

Complementing ONC's health IT, EHR software efforts

The move to regulate EHR software is in lockstep with other FDA initiatives in the health IT space, Patel said. CDRH already regulates some medical software, such as picture archiving and communications systems and applications that analyze radiology films. The agency can transfer its expertise from those devices (as they're defined by the regulations) to EHR systems.

"Cardiology health systems are also regulated," Patel said. "We've been doing this since [the 1990s]. It's nothing new." The challenge the FDA is trying to solve is to find a balance between promoting EHR safety without stifling innovation out in the marketplace, he said.

Patel also sees the push to monitor and regulate EHR software as complementing the efforts of the Office of the National Coordinator for Health Information Technology (ONC) to help build a national, interoperable health data infrastructure.

"Our two-part mission is to promote and protect," Patel said. "The promote part is what ONC is leading. The protect part is also [important], so that people don't get harmed. … It's a tough balance, and we've faced this with every technology that's come through."

Let us know what you think about the story; email Don Fluckinger, Features Writer.

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